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    • 专利摘要:
    PISTON ACTUATED FRONT HANDLE AND SETPOINT DEPLOYMENT SYSTEM. The modalities include a system of implantation of a reference point with a knob configured for its actuation. A reference point can include one or more protrusions configured to engage one or more slots in a needle of the system. The needle can be configured to deliver a plurality of waypoints to a target location serially, one at a time. In certain modalities, the echogenic placement of reference points may have certain advantages. The handle includes an actuation mechanism with a ferrule and plunger actuating member configured to progressively or otherwise controllably deploy one or more reference points at once by advancing a stylet through and/or retracting the body. of a slotted needle in which the datums are disposed with a datum projection that extends into the needle slot, which also includes retaining structures that do not impede the needle lumen.
    公开号:BR112016029723A2
    申请号:R112016029723-7
    申请日:2015-05-14
    公开日:2021-06-22
    发明作者:Michael Clancy；Darach McGrath；Ciaran Toomey；Triona Campbell；Patrick Mulcahy；Fionan Keady
    申请人:Cook Medical Technologies Llc；
    IPC主号:
    专利说明:

    [0001] [0001] This application is a United States Non-Provisional Order claiming priority under Title 35 of United States Code § 119 for the Interim Order under serial number US 62/012,789, filed on 16th June 2014, which is incorporated by reference into this document in its entirety. FIELD OF TECHNIQUE
    [0002] [0002] The modalities disclosed in this document refer, in general, to a medical device system that includes one or more reference points and methods of use for the same. More particularly, the disclosed modalities relate to handle mechanisms and systems that include the same for endoscopic landmark implantation, and methods of use therefor. BACKGROUND
    [0003] [0003] Medical procedures often require the location and treatment of target areas in a patient. Focused dose delivery radiation therapy requires target location with a high degree of accuracy to limit damage to healthy tissue around the target. It is particularly important to know or estimate the precise target location in radiation oncology, as it is desirable to limit the exposure of adjacent body parts to radiation in a patient who is already suffering from the damage of cancer. However, in all treatment procedures, whether radiological or not, it is more desirable to be able to precisely target a region to be treated.
    [0004] [0004] In many applications, it is not possible to directly visualize a treatment target or portion of it (such as, for example, a cancerous tumor, cyst, pseudocyst or other target) that needs to undergo some action. As an example, when treating a lung or pancreatic tumor with radiation, it may not be possible to visualize the actual tumor within the patient immediately prior to radiation treatment. Therefore, it is highly advantageous to have some mechanism to allow the tumor to be located precisely so that radiation treatment can be focused on the tumor while avoiding damage to healthy tissue.
    [0005] [0005] Even for target regions that can be visualized using CAT scans (Computer Assisted Tomography), MRI (Magnetic Resonance Imaging), X-rays, ultrasound or other techniques, difficulties in targeting a treatment often arise. This is particularly true for target regions within a patient's torso and soft tissue regions. Due to tissue mobility in these regions (eg movement of internal organs during breathing and/or digestion, breast tissue movement with any change in body position, etc.), a target region may not remain fixed in relation to anatomical references and/or to markers that may be placed on an external surface of a patient's body during one of these visualization procedures.
    [0006] [0006] Several sets of procedures have been developed to address this problem. One set of procedures consists of placing markers on the patient along the margins of the target region. Markers can be active (eg, emit some type of signal useful in targeting a therapy) or passive (eg, non-ferromagnetic metallic markers – called landmarks – which can be used for targeting under ultrasound, MRI, rays X or other sets of bleaching procedures that can be included in a treatment device).
    [0007] [0007] A reference point is typically formed from a radiopaque material, so that the target can be located and effectively treated with a device that targets a site using the reference points as positional markers under radiographic detection . Typically, reference points can be inserted into the patient during a simple operation. Percutaneous placement is the most commonly used. However, the use of minimally invasive placement through an endoscope has recently developed landmark placement into a patient's internal organs. For example, the percutaneous placement of landmarks along the margins of a pancreatic tumor can be complex and painful (particularly for obese patients, when the needle size is necessarily larger). Another process that uses objects percutaneously implanted in a patient is brachytherapy. In brachytherapy, radioactive sources or “seeds” are implanted into and/or adjacent to a tumor to deliver a high dose of radiation to the tumor, but not to the healthy tissue surrounding the tumor.
    [0008] [0008] Figures 1A and 1B show longitudinal sectional views of a prior art two-piece introducer 100 useful for placement of seeds or brachytherapy landmarks. Referring primarily to Figure 1A, introducer 100 includes a needle 102 and stylet 104 slidably disposed within needle 102. Stylet 104 includes a first handle 101 and a blunt distal end 106. Needle 102 includes a second handle 103 and a bevel-tipped cannula 108 that extends through the second handle 103. The cannula 108 is configured to contain a seed/reference point 110. The cannula 108 has a distal tip 105 configured for percutaneous implantation of the seed/reference point 110 in the patient.
    [0009] [0009] In a "pre-loaded configuration", the seed/setpoint 110 is retained in the cannula 108 by a plug 112 made of bone wax or other (or other) biocompatible (or biocompatible) material (or materials). This is typically accomplished by a set of “nozzle loading” type procedures in which the reference point is placed on the distal needle and then held in place by the bone wax plug. This can present some challenges as the bone wax plug 112 can be visible as an artifact in the patient, potentially interfering with clear visualization of body structures or treatment devices. With this configuration, cannula 108 needs to be removed and refilled after delivery of each seed/setpoint 110. If target locations for setpoints are too far away, use a single cannula/percutaneous introducer exchange to multiple insertions of the cannula 108 may not be possible. In such a circumstance, the patient must endure multiple percutaneous perforations (and the accompanying increased risk of infection for each).
    [0010] [0010] To implant the desired seed/setpoint 110 arrangement at a target location on a patient, an operator pushes cannula 108 in a first direction (arrow A) to insert tip 105 into the patient (typically under fluoroscopic visualization ). The operator then pushes the second handle 103 further in the first direction to position the tip 105 at the desired depth within the patient where a seed/reference point 110 is to be implanted. During this movement, the operator moves needle 102 and stylet 104 together as a unit. At the desired depth/location, the operator holds the first handle 101 with one hand and the second handle 103 with the other hand. Then, the operator holds the first handle 101 stationary while simultaneously sliding the second handle 103 back in a second direction (arrow B) toward the first handle 101. As shown in Figure 1B, this movement causes the cannula 108 retract over the seed/setpoint 110 to implant it in the patient. Alternatively, the operator can move the first handle 101 in the first direction (arrow A) while sliding the second handle 103 back in the second direction (arrow B). This causes the stylet 104 to push the seeds 110 out of the cannula 108. The procedure is then repeated to place other seeds/reference points 110. When used for radiation therapy targeting, a minimum of three points of reference is typically required.
    [0011] [0011] As will be seen from the disclosed structure, after deploying a reference point, the introducer 100 can be alternatively reloaded from the proximal end by completely withdrawing the stylet 104, then placing another reference point into the needle lumen and advancing it therethrough to a second location to which the distal needle tip 105 has been directed (a set of "cartridge loading" type procedures). As long as the landmark target sites are close enough to allow this set of procedures, this can reduce the number of percutaneous punctures or other access procedures required to place more than one landmark. However, this creates a problem for procedures when ultrasound is being used or is to be used in the near future due to the fact that it introduces air pockets into tissue and related fluids. These tissue and/or fluid air pockets are echogenic in a way that can interfere with ultrasound visualization of a target area and/or tools that are used for diagnosis or treatment of/around the area. In some sets of brachytherapy procedures, a series of landmarks may be preloaded into the needle – either separately or connected by a suture or similar device – then placed very close together; however, such a set of procedures is typically not effective for placing three or more landmarks in locations sufficiently distinct to use targeting a treatment in relation to, for example, the margins of a tumor. This can also be true for systems with multiple waypoints that rely on a distal plug to retain the waypoints, which are later released freely, in contrast to systems in accordance with the present invention, which are configured for release in controlled series (eg, one at a time, two at a time, or some other controlled retention and release of a predetermined number of reference points).
    [0012] [0012] The process is similar when implanted endoscopically in the newly developed manner, except that the needle and stylet are of the type known in the art for use through the working channel of an endoscope. A limitation of current endoscopic procedure sets is the reference point size that can be introduced. With the limited size of endoscope working channels, the largest needle that can typically be used without risk of bending, crimping, bending or other damage to a needle (which does not have an internal stylet or other support) during outward advancement The endoscope for an anatomical target is a 19-gauge needle. This limits the size of the reference point that can be introduced through the needle lumen using current cylindrical reference points. The set of endoscopic procedures generally suffer from the same recharge problems as described above. Although external percutaneous punctures are not a problem, having to remove and reload takes valuable time and complicates the procedure, potentially requiring additional staff, if only the stylet is removed for "cartridge loading" or the entire device is removed for " nozzle loading”.
    [0013] [0013] It would be desirable to use ultrasound and particularly endoscopic ultrasound (EUS) for navigation and landmark placement. Therefore, it would be desirable to provide and use the largest possible reference point that will provide enhanced echogenicity based on its size and echogenic profile. It will be desirable to provide multiple reference points on a needle that can be introduced in a controlled series manner (one or some other predetermined number at a time) preferably requiring manual refill after placement of each reference point. BRIEF SUMMARY
    [0014] [0014] Embodiments of a reference point deployment system described herein may include one or more of: one or a plurality of reference points having one or more protrusions, a slotted needle configured to deliver a plurality of serial datums where the groove receives the datum protrusions without an indentation occupying any portion of the inner diameter needle lumen, a knob configured to control serial delivery by user-operated implantation of a predetermined number of landmarks, and a method of delivering landmarks in a target region. BRIEF DESCRIPTION OF THE DRAWINGS
    [0015] [0015] Figures 1A to 1B show a prior art landmark introducer and method of use;
    [0016] [0016] Figures 2A to 2C show an embodiment of a reference point of respectively top, side and cross-sectional views.
    [0017] [0017] Figure 3 shows a top view of a slotted needle modality;
    [0018] [0018] Figure 3A shows a top view of another grooved needle modality;
    [0019] [0019] Figures 4 to 4B show, respectively, a top perspective view, a longitudinal sectional view and a cross sectional view of a distal portion of the reference point deployment system;
    [0020] [0020] Figures 5A to 5C show a method of placing reference points;
    [0021] [0021] Figures 6A to 6B show a handle embodiment for a reference point deployment system; and
    [0022] [0022] Figures 7 to 7G show, respectively, an external view, an internal component view and views of method of use/function of an advance mechanism modality for a reference point deployment system. DETAILED DESCRIPTION
    [0023] [0023] The terms "proximal" and "distal" are used herein in the sense of common usage, in which they refer, respectively, to a physician handle/end of a device or related object and a patient tool/end of a device or related object.
    [0024] [0024] A variety of reference point and needle configurations may be used in maintaining the present embodiments, including those described in Patent Application Publication Nos. 2010/0280367; 2011/0152611 by Ducharme et al.; 2013/0006101 by McHugo et al.; 2013/0006286 by Lavelle et al.; and 2013/0096427 of Murray et al., which are incorporated by reference herein in their entirety. One embodiment, illustrated with reference to Figures 2A to 2C, of a reference point 400 has a generally columnar body that is generally cylindrical with a generally circular cross-section. A longitudinal surface face of the body can be perforated to enhance its ability to reflect ultrasound waves and thereby provide a desirable echogenic profile. This perforated feature can alternatively be incorporated as a different irregular surface feature, patterned or textured (for example, endowed with ribs or friezes) that can accentuate the echogenicity of the reference point 400, which will aid in its visualization during guided placement by EUS, and allow it to be used in ultrasound visualization of a target site that is marked by one or more 400 landmarks (eg, a tumor).
    [0025] [0025] Such reference point 400 will preferably be formed of a radiopaque non-ferromagnetic material such as, for example, gold, platinum, palladium, iridium or alloys thereof, with a preferred embodiment including an alloy of palladium with rhenium (whose advantages may include desirable radiopacity, market price stability superior to gold, and ultrasound reflectivity/ecogenecity due to density). Being radiopaque will allow the reference point to be used in sets of implantation procedures that use fluoroscopy, as well as make it detectable/viewable by radiographic means during a treatment or other procedure where it may be desirable to know the location (or locations) of one or more landmarks. Being non-ferromagnetic will decrease the likelihood that sets of visualization procedures or other procedures that employ magnetic fields, such as, for example, MRI, will reorient or otherwise dislodge a reference point. The echogenic construction of a reference point or needle can be accentuated by surface texture, but it can also be provided by structural inclusions such as embedded bubbles or microspheres that provide a different ultrasound reflectivity than the surrounding material. The reference points can also be coated with a material (eg parylene) configured to reduce back diffusion during radiography.
    [0026] [0026] In a preferred embodiment, the reference point 400 is configured and sized for passage and release of a needle lumen. For an endoscopic delivery system, the reference point body 402 (exclusive of the bulge) will preferably have an outside diameter (OD) approximately equal to or smaller than the inside diameter (ID) of a needle lumen, but the The datum body OD will preferably be no greater than the needle ID. As used herein, the datum OD refers to an imaginary circle (or other geometric shape) whose outermost boundaries will fit the ID of the needle lumen. In other words, it is preferred that the datum is sized to slidably fit the needle lumen, except for the bulge, which protrudes into the groove.
    [0027] [0027] The longer body distal portion of the bulge can help ensure that, during implantation through a needle, a first reference point distal from that second reference point will be fully advanced out of the needle before the second reference point. reference is positioned for deployment, as will become clearer with reference to Figures 7-7G below. Consequently, in many preferred embodiments, the datum bulge (of the second and successive datum points) will be closer to its proximal end than to its distal end, so that the distal portion of the datum body will fit. project sufficiently distally, which will advance the preceding first reference point completely out of the needle lumen by as long as the second reference point is in a position to be deployed (see Figures 4A to 4C, 7D, 7E and the corresponding text). It should be noted that, even if all surfaces of the central portion of the reference point 402 and the protrusion 408 are generally smooth, the preferred materials that form the reference point 400 and the presence of the protrusion 408 can provide a desirable echogenic profile that it is readily viewable under ultrasound at a resolution sufficient to locate and/or navigate it in a patient's body.
    [0028] Reference point 400 has a generally cylindrical body 402 formed as a mass with a generally circular cross-section along its proximal and distal end cuts. A protrusion 408 protrudes from the longitudinal circumferential face 406 of the datum body 402. As viewed from the top, the protrusion 408 is generally rounded. The irregular shape and increased surface area (compared to a typical cylindrical reference point of the type used in cap-end systems and/or systems with some type of lumen-occupying indentation) preferably accentuate the echogeneicity of the reference point, which, preferably, will already be desirably high due, in part, to its composition.
    [0029] Protrusion 408 includes protrusion 407 end faces that may provide one or more of a beveled, filleted, and spoked transition to the outer face 406 of body 402. Body 402 is generally a straight cylinder, except for the protrusion 408. In this embodiment, protrusion 408 is rounded and substantially parallel to the central longitudinal axis of the datum body, and is about half the length of the body 402, and is centered along the length of the body. In a preferred embodiment, reference point 400 is configured and sized to pass and release a needle lumen. For an endoscopic delivery system, the reference point body
    [0030] [0030] The dimensions of an exemplary embodiment are also described with reference to Figures 2A to 2C. In an exemplary embodiment, body 402 is about 0.12 inches (3.05 mm) long and has an OD of about 0.034 inches (0.86 mm). Lump 408 is about 0.06 inches (1.5 mm) long and is aligned along an intermediate line on the body. Lump 408 protrudes about 0.008 inches (0.2 mm) above the OD of body 402 and is about 0.011 inches (0.28 mm) wide. These measurements and proportions may be varied in other embodiments, although they remain within the scope of the material presently claimed. For example, the bulge may be more distally or proximally located, and may be at an angle to the midline so that it is arranged partially in a spiral shape around the outer surface of the body.
    [0031] [0031] Figure 2C shows an end view of a cross-section taken along line 2C-2C of Figure 2A. This shows a modality of general proportions of a body and a reference point bulge of the present system.
    [0032] [0032] Figure 3 shows an embodiment of a reference point introducing needle 800. Needle 800 is illustrated with a beveled distal tip 802. Its tubular cannula body 804 includes a longitudinal needle slot 806 along a region of distal end of the cannula
    [0033] [0033] In the embodiment of Figure 3, the indentation is formed as a narrowed portion 807 of slot 806 between two tabs 808.
    [0034] [0034] The body wall cannula 804 generally circumferentially defines an 810 needle lumen configured to allow sliding passage therethrough from a reference point such as, for example, a reference point (e.g., as per shown in Figures 2A to 2C or others that would readily pass through the needle lumen 810, preferably with controllable retention of the reference point (or points) by the tabs 808). The needle can be constructed from an alloy of nickel and titanium, alloy of cobalt and chromium (CoCr), stainless steel or any other suitable material. Your tip may have a different geometry than the chamfered configuration shown. In an alternative embodiment, tabs 808 may meet so that they are forced to flex upward and/or outward to a greater degree to allow passage of a protrusion at a reference point. And, the outer surface of the needle can be pierced or otherwise textured to provide enhanced echogenicity.
    [0035] [0035] An exemplary needle embodiment is also described with reference to Figure 3, which exemplary needle embodiment may be configured and sized for use with the exemplary reference point embodiment described above with reference to Figures 2A to 2C. In such an exemplary needle embodiment, the ID of the needle lumen is at least about 0.034 inches (0.86 mm). Needle OD is about 0.042 inches (1.07 mm; about 19 gauge), with a wall thickness of about 0.008 inches (0.2 mm). The grooved proximal portion of the tabs is about 0.02 inches (0.5 mm) wide and about 0.42 inches (about 10.7 mm) long. Each of the tabs extends about 0.06 inches (0.15 mm) away from the groove edge and has a groove facing edge that is about 0.02 inches (0.5 mm) long (not including the proximal and distal angled groove edge transitions, which are radiused at about 0.005 inches (0.13 mm)). These measurements and proportions may be varied in other embodiments, including those illustrated herein, while remaining within the scope of the material presently claimed. For example, the particular dimensions of a groove, tabs, and datum can be configured for use with a 22 gauge needle that has a desirable balance of flexibility and rigidity, as well as including a needle tip distal bevel of about 30 °, a groove width of about 0.014 inches (about 0.36 mm) with groove tabs only about 0.006 inches (about 0.15 mm) apart through the groove, and echogeneicity enhancing surface perforation disposed along the exterior of the needle adjacent and generally parallel to at least a distal length of the slot.
    [0036] [0036] The distal end portion of a 1000 reference point deployment system is described with reference to Figure 4, which is an external view, to Figure 4A which is a longitudinal sectional view taken along line 4A-4A of Figure 4, which uses needle 800 and reference point 400 described above, and to Figure 4B, which shows a cross-sectional view along line 4B-4B of Figure 4A. System 1000 includes a flexible elongated needle sheath 1002. Needle 800, which includes a more flexible proximal body portion 820, extends through a sheath lumen 1004. At least one reference point 400, illustrated herein as a plurality of reference points 400, is removably and slidably disposed in a distal region of the needle lumen 810 of the needle cannula body. The central longitudinal body portion 402 substantially occupies the inside diameter of the needle lumen 810. The protrusion 408 of each reference point 400 has a height that can be about the same thickness as the needle wall, which includes the slot 806 in which the lumps 408 protrude.
    [0037] The bulge 408 of the most distal reference point 400 is captured against the tabs 808 of the needle 800. A stylet 1006 configured for use as a propeller is disposed through a portion of the lumen of needle 810 and is preferably configured for actuation from the proximal end, through which it can be used to advance/push the landmarks distally and/or hold them in place as the needle is withdrawn from their surroundings. The presence of the reference points and stylet on needle 800 preferably improves its columnar strength, reduces the likelihood that they will be flexed, crimped, or otherwise damaged as they are navigated through and out of the distal end of an endoscope working channel (not shown).
    [0038] [0038] Figure 4B shows an end cross-sectional view of a section of a needle 800 (as in Figure 3) and a reference point 400 (as in Figures 2A to 2C). This view shows the preferred tight tolerances and a preferred orientation of the datum body with respect to needle lumen 810 and protrusion 408 with respect to needle groove 806.
    [0039] [0039] Several different handle modes can be used to advance and release one or more reference points. Certain embodiments of the handle are described with reference to Figures 7 to 7G below, including with reference to the structure and method described below with reference to Figures 4 to 4B and 5A to 5C.
    [0040] [0040] A method of using the reference point implantation needle of Figures 4 to 4B is described with reference to Figures 5A to 5C, in reference to the structures shown in greater detail in Figures 4 to 4B. In a preferred method, an endoscope 1100 is provided that includes a working channel 1102. In a preferred method, the endoscope is an EUS endoscope that includes a distal ultrasound array 1104 configured for ultrasound imaging. Endoscope 1100 also preferably includes a video element 1106 (e.g., CCD, optical camera, or other means for optical viewing). The methods below are described with reference to placing landmarks 400 on the margins of a tumor 1152 of a pancreas from patient 1150 so that the needle body will have sufficient length and navigability (e.g., thrust and flexion capability) to be perorally directed through a patient's gastrointestinal tract to a target site, which includes doing so through a working channel of an endoscope such as a gastric endoscope, colonoscope, anoscope, or other visualization/procedural aiding device.
    [0041] [0041] Endoscope 1100 is shown in Figure 5A as having been directed through a duodenum of patient 1140 until its distal end portion is adjacent to sphincter of Oddi 1142, which provides access to common bile duct 1144 from which the pancreatic duct 1146 branches and leads to pancreas 1150.
    [0042] [0042] As shown in Figure 5A, sheath 1002 was advanced to the wall of the duodenum and needle 800 pierced it, extending close to pancreatic duct 1146 to a location adjacent to tumor 1152 in pancreas 1150. As shown in Figure 5B , the 800 needle is directed to a first target site on an 1152 tumor margin (preferably under ultrasound guidance, which can be replaced, supplemented and/or verified by fluoroscopy or another set of visualization procedures). Once the distal end 802 of needle 800 is positioned on the first target, the most distal reference point 400 thereon is implanted. In one aspect, implantation can be accomplished by positioning the distal end of needle 802 and reference point 400 therein on the first target, then retracting needle 800 while retaining the position of stylet 1006 such that the point reference 400 remains in the first desired target position. In another aspect, implantation can be accomplished by positioning the distal end of needle 802 and reference point 400 therein adjacent to the first target, then holding needle 800 in position while advancing stylet 1006 so that reference point 400 is advanced to the first desired target position.
    [0043] [0043] As will be seen from the structure of the needle 800 and the reference points 400 as shown in Figures 4 to 4B, a user will preferably be able to control the advancement/deployment of the reference points one at a time, from so that a plurality of reference points (without any spacers) can be serially – but separately and independently – directed to different locations. The reference point 400 is then in a "ready to deploy" position, its distal bulge face 408a is engaged with the proximal tab edges 808a. To deploy the 400 reference point, the user needs to move one of the stylus
    [0044] [0044] The user will preferably have a tactile sense of resistance as the bulge 408 passes through the tabs 808, which resistance will immediately decrease as the bulge is freed from the tabs. The user then preferably continues the relative movement of stylet and needle until resistance is again encountered, indicating that the next reference point behind the most distal has encountered the proximal flap edges 808a.
    [0045] [0045] It will often be preferred that the reference points (and the bulges therein) are proportionate such that the full deployment of a more distal reference point includes it substantially free of the distal needle tip 802 and coincides with the bulge from the next most distal reference point that meets the proximal flap edges 808a. Thus, it may be advantageous in some datum arrangements to position the protrusion more proximally to the datum body so that a distal portion of the protrusion datum body is longer than a proximal portion of the protrusion body. It should be noted that the bulge of almost any datum modality in maintenance with principles of the present invention can be disposed close to the proximal end and including flush with the proximal end of the datum body). Figure 5C shows the reference point in place, with the needle removed from it.
    [0046] [0046] Next, the user can retract needle 800 in sheath 1002 to a sufficient distance to allow it to be extended again to a second target site, where the procedure described above can be repeated. These steps can be repeated for placement of third, fourth, and more landmarks. As is known in the art, these reference points can be used for "positive targeting" and/or "negative targeting" of a therapy such as radiation therapy ("positive targeting" indicating "treat here", and "negative targeting" indicating “do not treat here”). The present system has several advantages. For example, consider a patient who has already undergone an endoscopy procedure to biopsy a localized but undiagnosed tissue mass. Endoscopic biopsy can be adopted and a tissue slide prepared immediately. If a diagnosis is made (together with any other data that are available and pertinent) in which the tissue mass will benefit from a treatment where placement of reference points is indicated, the physician can immediately implant the reference points of the way described above.
    [0047] [0047] The ability to complete the method using ultrasound and direct/video imaging with little or no use of fluoroscopy has an advantage of minimizing the patient's radiation exposure (who may, for example, have undergone therapies with radiation where the total amount of radiation exposure is desired to be minimized to what is therapeutically and diagnostically necessary). The time and expense advantages for the patient, physician and other staff for treatment/diagnosis and ease of treatment are likely as implementation of the present method may prevent all of these entities from having to schedule and conduct a second endoscopic and/or extend procedure the initial diagnostic procedure with the time-consuming methods and materials currently available in the prior art as described. It should also be noted that, when informed by the present disclosure, those skilled in the art may utilize and/or adapt the presently disclosed modalities for percutaneous use while remaining within the scope of one or more claims.
    [0048] [0048] Reference points with generally cylindrical or otherwise generally regular geometry may migrate after being placed in a desired location, which includes that - over the course of multiple treatments of a delineated target area by landmarks – they can migrate with changes in the condition of surrounding tissues. For circumstances where it might be advantageous to minimize migration, a reference point that includes one or more anchoring projections can be used.
    [0049] [0049] Figures 6A to 6B show a handle mod 1600 that can be used with a reference point deployment system. Handle 1600 includes a handle member secured to sheath 1602 with a handle member secured to needle 1604 longitudinally slidably disposed at its proximal end. A handle member 1606 (which can be configured for scope attachment) is slidably secured to the distal end of the handle member secured to sheath 1602. The handle member secured to sheath 1602 is secured to needle sheath 1612 and the member of handle attached to needle 1604 is attached to needle 1614 (which may be configured in the manner of any of the needles disclosed herein or further developed in accordance with the principles of the present disclosure). Scope clamping handle member 1606 is configured for progressively attachable and longitudinally adjustable attachment (relative to other handle components) to the exterior of an endoscope working channel (not shown) using, for example, a threaded cavity 1616 The scope clamping knob member 1606 allows a user to determine the distance that the sheath 1612 will extend from a standard length endoscope, and may include numeric symbols or other 1617 symbols that correspond to relative length and a 1618 adjustable hitch frame that allows a user to select a length and engage the 1606 scope clamping knob member accordingly. It should be noted that the embodiments of the handle described and claimed herein can be practiced within the scope of the present invention without including a scope-fixing member.
    [0050] The handle member attached to the sheath 1602 includes numerical symbols 1608 and an adjustable ring 1609 that limits the movement of the handle member attached to the needle 1604 and provides a way to select the distance by which the needle 1614 can be extended beyond the 1612 sheath. By way of illustration, the configuration shown in Figure 6A would allow the sheath to extend 5 units (eg, inches, cm) beyond the distal end opening of an endoscope working channel, and the 1614 needle would not would extend all the way beyond the distal end of the 1612 sheath. The configuration shown in Figure 6B would allow the sheath to extend 3 units (eg, inches, cm) beyond the distal end opening of an endoscope working channel, and allow needle 1614 would be extended up to 6 units beyond the distal end of sheath 1612,
    [0051] [0051] A 1610 stylet extends through a lumen of the 1614 needle and has a 1611 stylet cap attached to its proximal end. Stylet 1610 is shown as being retracted proximally in Figure 6A, and extended beyond the distal end of needle 1614 in Figure 6B. Stylet 1610 can be manually advanced distally through the needle lumen in the same manner as described above (referring to Figures 4 to 4B) for a stylet 1006. Thus, a user can use the stylet to manually push the reference points outward from a distal end of needle 1614. If this method is used (for example, in the manner described above for setting reference points with reference to Figures 4 through 5C), a user may rely on tactile feedback to determine when a reference point has been advanced beyond any indentations, which can be difficult using a long stylet – particularly if the indentations are rounded so that the forward movement is relatively smooth. Consequently, it may be advantageous to provide a feed mechanism configured to secure (which includes being integrated with) the handle 1600 which provides improved control of stylet feed.
    [0052] [0052] Figures 7 to 7G show modalities of advancing mechanisms that can be used with handle mounting configurations similar to those of Figures 6A to 6B, or other handle configurations (which include, for example, those disclosed in the Patent Applications US 2010/0280367 and US 2011/0152611 to Ducharme et al.; US 2013/0006101 to McHugo et al. US 2013/0006286 to Lavelle et al; and US 2013/0096427 to Murray et al.). Figures 7 through 7G show a 1750 piston-actuated handle component for a landmark deployment system. In this and other embodiments, handle member 1750 may be removably or permanently attached to, or otherwise integrated with, a proximal end of a handle, such as proximal end 1605 of the handle member attached to needle 1604 shown in Figures 6A to 6B, where it will provide a means for controlled advancement of a stylet (e.g., stylet 1610) in place of direct and/or manual manipulation of the stylet cap 1611.
    [0053] [0053] Plunger handle component 1750 may include at least one actuation piston member 1770 incorporated as a longitudinally slidable piston and a first elongate handle body member 1754 that includes and defines a central longitudinal axis and a lumen of handle. Plunger Handle Component 1750 may be attached directly or indirectly to a cannula (eg, needle and/or sheath), such as through an elongated distal outer body that has a longitudinal body lumen (eg, in some embodiments). , handle member attached to sheath 1602, or, in other embodiments, a needle with datum and/or sheath). A stylet 1760 (which may correspond to a stylet 1610) extends through at least a portion of the first handle member body 1754 along or generally in line with its central longitudinal axis.
    [0054] [0054] A user-operable portion of actuating plunger member 1770 is movably disposed at the proximal end of the first handle member body 1754 and extends longitudinally through at least a portion of the central longitudinal axis of the handle and the handle lumen. Actuation piston member 1770 is secured to or otherwise engaged with an elongated ferrule 1762 that similarly includes and defines a central longitudinal axis and ferrule lumen 1763. In some embodiments, ferrule 1762 may be formed having a cylindrical inner surface defining the ferrule lumen and a conical outer surface. A collar 1768 includes and defines a central longitudinal axis and collar lumen and is removably or slidably engaged surrounding the distal end of ferrule 1762. Stylet 1760 extends through at least a portion of ferrule 1762 and the lumen of 1763 ferrule along or generally aligned with its central longitudinal axis. The distal end of actuating plunger member 1770 is engaged by and oriented or urged toward the proximal end of the first handle body member 1754 by a compression spring 1764, although those skilled in the art will note that this proximal direction bias it can be accomplished by a variety of means without departing from the scope of the present disclosure.
    [0055] [0055] While at rest, actuating plunger member 1770 is held in a fully pulled posterior position, as shown in Figures 7A and 7B, by the proximal direction bias of compression spring 1764. In that position, at least a portion of the ferrule 1762 is contained in elongated stop housing 1766, which includes and defines a central longitudinal axis and housing lumen. Stop housing 1766 further defines a first laterally projecting upper stop lip and a second laterally projecting lower stop lip at the distal end of the housing lumen along or generally in line with its central longitudinal axis. The upper stop edge of the stop housing 1766 is engaged by the distal end of the compression spring 1764. The proximal end of the compression spring 1764 engages the distal end of the actuating plunger member 1770. While at rest, the compression spring 1764 exerts sufficient force to hold the 1770 actuating plunger member in a fully pulled posterior position within the 1754 handle member.
    [0056] [0056] When actuating plunger member 1770 is in the fully pulled back position, collar 1768 is at least partially contained within the distal end of stop housing 1766 and is engaged by the distal/bottom end end surface defining a bead of the stop housing stopper 1766. A laterally projecting snubber plate 1772 is also formed in an inner wall of the handle lumen of the first handle body member.
    [0057] [0057] Plunger member 1770 also defines vertically projecting actuating members - incorporated herein as pleats 1782 - on the distal edge of piston member 1770, which, during user operation, may engage one or more vertically projecting actuating members formed at the proximal end of the 1776 rotationally activated indicator display. In one embodiment, as shown in Figures 7-D and F, vertically projecting actuating members formed at the proximal end of the 1776 rotationally actuated indicator display are incorporated as tapered or oriented 1780 teeth which are angled to a predetermined degree and length, although those skilled in the art will appreciate that the actuation of the rotationally actuated indicator dial 1776 can be accomplished by a variety of means without departing from the scope of the present disclosure. The outer surface of the 1776 indicator dial is shown in the figures as having 1778 numeric symbols that can be viewed through a 1774 window formed in the body of the 1754 handle body member. The 1778 numeric symbols (which, in other embodiments, may be colored bands or other similar visual symbols) can be used to provide a visual cue to the user allowing the user to identify information about the distance advanced by the distal end of the stylet from the actuation of the 1770 plunger member.
    [0058] [0058] With this structure revealed, the elements versed in the technique will observe a method of use. Figures 7B to 7G show general longitudinal perspective views of internal components, which include a method of operation for this modality. The distal advancement of the plunger member 1770 and stylet 1760, which corresponds to a datum deployment motion action or other gradual/progressive distal motion, is shown in an exemplary partial needle distal view of Figures 7D and 7E ( see also, for example, Figures 5B and 5C). As shown in Figure 7B, the plunger member 1770 can be actuated and lowered causing the vertical actuating creases 1782 projecting from the distal edge of the plunger member 1770 to engage the tapered or oriented teeth 1780 that project vertically formed at the proximal end of the rotationally driven indicator dial
    [0059] [0059] When the plunger member 1770, which is movably disposed at the proximal end of the handle member 1754 and extends longitudinally through at least a portion of the handle lumen along or generally in line with the central longitudinal axis of the handle, is distally advanced through the handle lumen, the elongated ferrule 1762 and the collar 1768, which is initially wrapped around the distal end of at least a portion of ferrule 1762, similarly advance distally through the handle lumen. Prior to initial actuation of plunger member 1770, as shown in Figure 7B, at least a portion of collar 1768 is contained within the distal end of the anvil housing housing lumen 1766 and is engaged by the lower anvil flange of the anvil housing. 1766. Collar 1768 is held tensioned around the distal end of ferrule 1762 by the lower stop edge of stop housing 1766 such that the jaws of the ferrule are compressed around or exert a gripping force on the wire of the 1760 stylet .
    [0060] [0060] As the user compresses actuating plunger member 1770, as shown in Figure 7C, distal advancement of ferrule 1762 causes collar 1768 to exit the distal end of stop housing 1766 and advance distally generally in line with The central longitudinal axis of the 1754 first handle body member. The 1762 ferrule, which is tightly compressed around the 1760 stylet, holds the 1760 stylet and advances distally along with the 1768 collar and 1760 stylet. As the 1768 collar advances in generally aligned with the longitudinal axis of the 1754 first handle body member, the 1768 collar reaches the cushion plate
    [0061] [0061] As ferrule 1762 continues to advance distally, ferrule 1762 advances distally from the distal end of collar 1768, as shown in Figure 7D. The 1762 ferrule, which is no longer compressed by the 1768 collar, expands to release its grip on the 1760 stylet. As the collar becomes less compressed around the 1760 stylet, the 1760 stylet is able to move independently of the 1762 ferrule. By the time ferrule 1762 has released its grip on stylet 1760, stylet 1760 will have advanced distally generally in line with the longitudinal axis of first handle body member 1754 by a predetermined distance that corresponds to the configuration and length of the plunger member 1770. The length and configuration of the plunger member 1770 limits the proximal/distal movement of the ferrule 1762 and, in turn, the stylet 1760, and is sized to match the desired progression of stylet advancement. In some embodiments, a number of reference points may be preloaded onto the distal end of needle 1614, and the desired progression of stylet advance corresponds to the length of advance required to serially deploy one or some predetermined number of points. Preloaded reference gauge 1790 from the distal end of needle 1614 as shown in the exemplary embodiment of Figure 7E. In one aspect,
    [0062] [0062] As the user or actuating device releases the plunger member 1770, the bias or proximal direction orientation of the compression spring 1764 causes the plunger member 1770 to advance proximally to return to the fully pulled posterior position. As plunger member 1770 is oriented or urged toward the proximal end of first handle body member 1754, ferrule 1762 and collar 1768 similarly advance proximally toward the proximal end of first handle body member 1754. As per the collar 1768 reaches the lower stop edge of the stop housing 1766, the collar 1768 is prevented from advancing proximally by any length. Ferrule 1762 continues to advance proximally with plunger member 1770 causing the distal end of ferrule 1762 to retract at the distal end of the collar.
    [0063] [0063] As illustrated in the embodiment of Figure 7G, depending on the configuration of the sheath 1612 and the needle 1614, which, in some embodiments, may be attached to the handle member attached to the needle 1604 or, in other embodiments, to the handle member 1750 , the stylet 1760 will have advanced a sufficient distance distally towards the distal end of the needle 1614 to deploy the desired number of reference points. In some configurations, the stylet will have advanced enough to deploy one or more reference points, but may remain disposed at least partially within needle 1614 and may have one or more additional reference points disposed within needle 1614 awaiting implantation. In this scenario, subsequent numbers of waypoints can be deployed by successive additional actuations of the 1770 plunger member.
    [0064] [0064] Those skilled in the art will note with reference to the embodiments disclosed above that a predetermined number of reference points can be released at a desired location by a single actuation of the lever, button or other actuating member. The predetermined number will preferably be one, but may include a plurality of reference points. The configuration of the present modalities provides clear advantages compared to prior art designs that use releasable end caps on a needle to retain the reference points, and/or that use less refined means of controlling the reference point release than the notch/flap needle design and/or actuation knobs described in this document.
    [0065] [0065] The drawings and particular features in the figures illustrating various modalities are not necessarily to scale. Some drawings may have certain details enlarged for emphasis, and any different numbers or proportions of parts are not to be read as limiting, unless so designated by one or more claims. Those skilled in the art will note that modalities not expressly illustrated in this document can be practiced within the scope of the present invention, which includes that the features described in this document for different modalities can be combined with each other and/or with currently sets of procedures known or developed in the future while remaining within the scope of the claims presented herein. For example, a needle and landmarks of the present system may be used percutaneously, which includes, in another minimally invasive surgical procedure, such as a laparoscopic type procedure, within the scope of the claimed invention. For example, a target site may be a location in or near the gastrointestinal tract (eg, liver, pancreas) such as those locations that can be accessed by endoscopy (using a minimally invasive endoscope introduced through a natural orifice of the patient, eg mouth, anus, vagina). This includes – more broadly – sites reachable through NOTES (natural orifice transluminal endoscopic surgery) procedures. The present method and device can also be used with other sets of minimally invasive surgical procedures such as percutaneous endoscopic procedures (eg, laparoscopic procedures) or percutaneous non-endoscopic procedures, but are most preferably used with less invasive endoscopy procedures.
    Therefore, the above detailed description is intended to be listed as illustrative rather than limiting.
    Furthermore, it is to be understood that the following claims, which include all equivalents, are intended to define the spirit and scope of this invention.
    权利要求:
    Claims (20)
    [1]
    1. Plunger-actuated ferrule handle for a reference point implantation system characterized in that said system comprises: a reference point implantation needle that retains the distal implantation, in a controlled series manner, of a plurality of reference points; an advancing mechanism configured for said reference point deployment, wherein the advancing mechanism comprises: an elongated handle member defining a central longitudinal axis and an inner handle wall; a central ferrule member longitudinally movable in the handle and defining a ferrule lumen, a distal end and a proximal end; a stylet disposed longitudinally through the implantation needle, extending proximally to the handle member and the ferrule lumen of the ferrule member; and a plunger actuating member extending distally to the handle member and affixed to the proximal end of the ferrule member and longitudinally movable in at least a portion of the handle member.
    [2]
    2. Handlebar according to claim 1, characterized in that the plunger actuating member is spring urged proximally, the central ferrule member is spring urged proximally, or both.
    [3]
    3. The handle of claim 1 or 2, further comprising a collar member slidably engaged with the distal end of the ferrule member which, when not secured, slides proximally along the ferrule member to the along the central longitudinal axis of the handle member.
    [4]
    4. Handlebar according to claim 3, characterized in that it further comprises a stop housing that defines a housing lumen and a proximal end.
    [5]
    5. Handle according to claim 4, characterized in that the stop housing further defines a lower stop edge that effectively prevents proximal movement of the collar member along the central longitudinal axis of the handle member .
    [6]
    6. Handlebar according to claim 5, characterized in that the collar causes the ferrule to exert a gripping force on the stylet when the plunger actuating member is at rest and the ferrule is engaged around the collar.
    [7]
    7. Handlebar according to claim 4, characterized in that it further comprises a damping plate arranged on the inner handle wall of the handle member and defining at least one damping stop edge.
    [8]
    8. The handle of claim 7, characterized in that the damping stop edge effectively stops the distal movement of the collar member along the central longitudinal axis of the handle member.
    [9]
    9. Handlebar according to claim 8, characterized in that the collar circumferentially releases the ferrule, which removes the gripping force on the stylet when the ferrule is advanced distally beyond the stop edge.
    [10]
    10. Handlebar according to any one of the preceding claims, characterized in that it additionally comprises an indicator display disposed on the handle member.
    [11]
    11. The handle according to claim 10, characterized in that the indicator display includes symbols, viewable through a window in the handle member, of the number of reference points deployed by the distal movement of the ferrule.
    [12]
    12. Handlebar according to claim 10, characterized in that the indicator dial is rotationally actuated by the distal movement of the piston actuating member.
    [13]
    13. Handlebar according to claim 12, characterized in that the piston actuating member further defines one or more vertically projecting actuating members.
    [14]
    14. Handlebar according to claim 13, characterized in that the indicator display further defines one or more vertically projecting set teeth that engage the one or more actuating members vertically projecting from the piston actuating member to actuate rotationally the indicator dial.
    [15]
    15. Medical device handle configured for stylet advancement in the controlled progressive length direction through a cannula such as a reference point needle, wherein the handle is characterized in that it comprises: an elongated outer handle body defining a longitudinal handle lumen; an elongated cannula attached directly or indirectly to a distal end of the handle body, the cannula defining a longitudinal cannula lumen in mechanical communication with the handle lumen; a plunger member disposed within the handle lumen; a ferrule disposed in the handle lumen and longitudinally movable in the handle lumen, wherein the ferrule is spring biased distally by a compression spring; a stylet extending distally from the ferrule to the cannula lumen; and at least one actuating member with a portion of the actuating member mechanically engaging the ferrule, wherein actuating the actuating member by moving it longitudinally relative to the longitudinal handle lumen is effective to move the ferrule distally by a predetermined progression .
    [16]
    16. Medical device handle according to claim 15, characterized in that the actuation of the actuating member by moving it transversely against and/or longitudinally in relation to the longitudinal handle lumen is effective to implant one or more points from a distal end of the cannula.
    [17]
    17. Medical device handle according to claim 15 or 16, characterized in that it further comprises a collar effective to compress the ferrule around the stylet.
    [18]
    18. Medical device handle according to claim 17, characterized in that the distal movement of the ferrule is effective to advance the distal movement of the stylet longitudinally in relation to the lumen of the longitudinal handle.
    [19]
    19. The medical device handle according to claim 18, further comprising a stop housing formed in an inner wall of the handle lumen and effective to prevent distal movement of the collar longitudinally relative to the handle lumen longitudinal.
    [20]
    20. Medical device handle according to claim 19, characterized in that the stop housing is effective to disengage the collar from a distal end of the stylet and to allow distal movement of the ferrule relative to the stylet.
    类似技术:
    公开号 | 公开日 | 专利标题
    BR112016029723A2|2021-06-22|plunger ferrule handle and reference point implantation system
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    CA2757870C|2016-02-02|System and method for fiducial deployment
    AU2015275132B2|2017-07-13|Screw-driven handles and systems for fiducial deployment
    US8838208B2|2014-09-16|Fiducial deployment needle system
    US8855747B2|2014-10-07|Engaged fiducials and system for deployment
    EP2719355A2|2014-04-16|Clutched-gear handle for fiducial deployment
    AU2015355303B2|2018-11-01|Endoscopic ultrasound fiducial needle stylet handle assembly
    AU2013215446B2|2014-12-04|Fiducial placement system and splayed stylet
    同族专利:
    公开号 | 公开日
    EP3154458B1|2018-08-29|
    WO2015195232A1|2015-12-23|
    AU2015277790A1|2016-12-22|
    CN106456150B|2019-02-12|
    AU2015277790B2|2017-06-08|
    US10363407B2|2019-07-30|
    JP2017518120A|2017-07-06|
    CN106456150A|2017-02-22|
    JP6302573B2|2018-03-28|
    EP3154458A1|2017-04-19|
    US20150360019A1|2015-12-17|
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    法律状态:
    2018-03-27| B15K| Others concerning applications: alteration of classification|Ipc: A61B 17/34 (2006.01) |
    2020-05-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|
    2021-10-05| B06A| Patent application procedure suspended [chapter 6.1 patent gazette]|
    2022-02-08| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    US201462012789P| true| 2014-06-16|2014-06-16|
    US62/012,789|2014-06-16|
    PCT/US2015/030735|WO2015195232A1|2014-06-16|2015-05-14|Plunger-driven collet handle and system for fiducial deployment|
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